Donepezil and Gut Microbiota in Alzheimer's

The study will take place in the Outpatient Department, Shanghai Research Institute of Acupuncture and Meridian, Shanghai, China, and the recruitment will be announced via our official account on social media. Placement of brochures and study posters in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine and Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (collaborating hospitals), and community centers will be used to assist recruitment. Participants or their representatives will be instructed to read the informed consent and those who showed interest in the study will be scheduled for the screening visit. After presenting written informed consent, participants will be examined, and if all entry criteria are met, will commence a 4-week run-in period of treatment with donepezil hydrochloride (5 mg/tablet, China) 5 mg daily (prior AD treatments will be terminated by then). To further avoid potential confounding effects on the clinical outcomes and gut microbiota, participants will be instructed to maintain their regular diet and activity level, and refrain from probiotics, prebiotics, or synbiotics use. Upon successful completion of the 4-week run-in, participants will be scheduled to complete baseline assessments and undergo randomization. The study flowchart and proposed trial schedule are shown in Figure 1 and Table 1, respectively.